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Zacks News
The company’s main area of focus is cystic fibrosis (CF). The company’s lead marketed products are Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko/Symkevi (tezacaftor in combination with ivacaftor), Orkambi (lumacaftor in combination with ivacaftor) and Kalydeco (ivacaftor), which are collectively approved to treat the majority of the people with CF in North America, Europe and Australia. Trikafta, Vertex’s triple combination regimen, was approved by the FDA in October 2019 for the treatment of CF in people aged 12 years and older who have at least one F508del mutation. Kaftrio (brand name of Trikafta in EU) was approved in the European Union in August 2020. It is also being evaluated in younger patients in the United States. With approval of Trikafta, Vertex can address a significantly larger CF patient population — almost 90% of patients with CF — in the future. Meanwhile, Vertex is pursuing genetic therapies to address the remaining 10% of CF patients. While CF remains the main area of focus, Vertex is also developing treatments for sickle cell disease, thalassemia and pain management.
Vertex Pharmaceuticals (VRTX) Gains As Market Dips: What You Should Know
by Zacks Equity Research
Vertex Pharmaceuticals (VRTX) closed at $188.57 in the latest trading session, marking a +0.26% move from the prior day.
What Makes Vertex (VRTX) a New Strong Buy Stock
by Zacks Equity Research
Vertex (VRTX) has been upgraded to a Zacks Rank #1 (Strong Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
Perrigo (PRGO) to Acquire Another Self-Care Company HRA Pharma
by Zacks Equity Research
Perrigo (PRGO) offers to acquire HRA Pharma with several leading OTC brands in its portfolio for almost $2.1 billion. The acquisition will complete Perrigo's transformation into a leading self-care company.
Global Blood's (GBT) NDA & sNDA for Oxbryta Get Priority Review
by Zacks Equity Research
The FDA grants priority review to Global Blood's (GBT) sNDA for Oxbryta to treat SCD in children aged four to 11 years, as well as to its NDA for a pediatric weight-based formulation of the drug.
The Zacks Analyst Blog Highlights: Regeneron, Vertex Pharmaceuticals and West Pharmaceutical Services
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Regeneron, Vertex Pharmaceuticals and West Pharmaceutical Services
A Short Trading Week: Global Week Ahead
by John Blank
The trading week is shorted to four days for stocks listed solely in the U.S. In turn, this Global Week Ahead looks to be dominated by non-U.S. events.
Bayer's (BAYRY) Chronic Cough Candidate Meets Efficacy Goal
by Zacks Equity Research
Bayer (BAYRY) posts positive data from the phase IIb PAGANINI study which is evaluating its investigational candidate, eliapixant, in patients with refractory chronic cough.
Roche's (RHHBY) Sparks Set to Develop Gene Therapy for HD
by Zacks Equity Research
Roche's (RHHBY) Sparks enters into a collaboration agreement with NeuExcell Therapeutics to develop a novel gene therapy for HD.
AstraZeneca's (AZN) Ultomiris Gets EU Nod for Rare Disease in Kids
by Zacks Equity Research
AstraZeneca's (AZN) Ultomiris receives expanded approval in the EU to treat children and adolescents with PNH, a rare disease.
Pfizer (PFE) Begins Study on RSV Vaccine in Older Adults
by Zacks Equity Research
Pfizer (PFE) starts a phase III study which will evaluate its respiratory syncytial virus vaccine candidate, RSVpreF in adults aged 60 years and above.
3 Large Biotech Stocks Worth Adding to Your Portfolio
by Zacks Equity Research
REGN, MRNA & VRTX are the three biotech companies that are likely to outperform the sector on the back of strong fundamentals.
FibroGen (FGEN) Meets Main Goal in Chemo-Induced Anemia Study
by Zacks Equity Research
FibroGen (FGEN) announces positive top-line data from the study of its investigational candidate roxadustat, which is being evaluated to treat chemotherapy-induced anemia.
AstraZeneca's (AZN) Rare Disease Study Meets Primary Goal
by Zacks Equity Research
AstraZeneca's (AZN) phase III study evaluating ALXN1840 for Wilson disease achieves primary endpoint. The company also receives approval in Japan for Forxiga to treat chronic kidney disease.
Stealth (MITO) Files NDA for Ultra-Rare Disease Candidate
by Zacks Equity Research
Stealth BioTherapeutics (MITO) files a new drug application for elamipretide to the FDA for the treatment of Barth syndrome, an ultra-rare genetic condition.
Vertex (VRTX) Inks New Deal for CRISPR Gene-Editing Rights
by Zacks Equity Research
Vertex (VRTX) collaboration with Arbor will support discovery & development of new treatment options for serious diseases using the latter's CRISPR technology.
Bristol Myers' (BMY) sBLA for Orencia Gets FDA Priority Review
by Zacks Equity Research
The FDA accepts Bristol Myers' (BMY) sBLA for Orencia under a priority review to prevent moderate to severe acute graft versus host disease. A verdict is pending on Dec 23, 2021.
QIAGEN's (QGEN) Kits Hit New Milestone for Sample Preparation
by Zacks Equity Research
QIAGEN's (QGEN) consumables kits have been utilized to process more than 3 billion biological samples, emphasizing on its leading position in sample preparation.
AstraZeneca (AZN) Stops Phase III Study on Ultomiris for ALS
by Zacks Equity Research
AstraZeneca (AZN) stops the phase III CHAMPION-ALS study on Ultomiris for treating adults with amyotrophic lateral sclerosis, following a recommendation from the Independent Data Monitoring Committee.
Paratek's (PRTK) Nuzyra Gets FDA's Orphan Drug Tag for NTM
by Zacks Equity Research
The FDA bestows an Orphan Drug designation to Paratek's (PRTK) marketed drug Nuzyra for the treatment of infections caused by Nontuberculous Mycobacteria.
Werewolf (HOWL) Up on Deal With Merck for Solid Tumor Study
by Zacks Equity Research
Werewolf Therapeutics (HOWL) inks a collaboration and supply agreement with Merck to evaluate its candidate, WTX-124, in combination with Keytruda, for treating solid tumors. Stock up.
Zacks.com featured highlights include: SunOpta, Rent-A-Center, Sterling Construction, Vertex Pharmaceuticals and Alto Ingredients
by Zacks Equity Research
Zacks.com featured highlights include: SunOpta, Rent-A-Center, Sterling Construction, Vertex Pharmaceuticals and Alto Ingredients
Bet on 5 Top-Ranked Stocks With Rising P/E
by Sanghamitra Saha
Inside the top-ranked stocks that can beat earnings estimates in their next releases.
Glaxo's (GSK) Jemperli Gets FDA Approval for New Indication
by Zacks Equity Research
The FDA grants accelerated approval to Glaxo's (GSK) Jemperli for treating patients with mismatch repair-deficient recurrent/advanced solid tumors. This is the second approved indication for the drug.
Mei (MEIP) Begins Phase III Study for B-Cell Malignancies
by Zacks Equity Research
Mei Pharma (MEIP) doses first patient in phase III study to evaluate zandelisib plus rituximab in follicular lymphoma or marginal zone lymphoma.
Aurinia (AUPH) Adds Two Candidates, Boosts Immunology Pipeline
by Zacks Equity Research
Aurinia (AUPH) acquires two pre-clinical, novel pipeline programs for the treatment of rare autoimmune, fibrotic and kidney diseases. Yet, the stock price declines.